Oversight Info

Has Dmc

Is Fda Regulated Drug

Is Fda Regulated Device

Brief Summary

Detailed Description

The aim of this study is to mechanically characterise saphenous and popliteal vein segments
that have been deemed waste following varicose vein procedures, lower limb amputation and
lower limb bypass surgery.
By characterising the stress-stretch relationship of the vein vessel wall, treatment
techniques can be better understood. Mechanical device design can be bteer informed and the
the suitability of vein as a conduit for bypass and AVF procedures can be assessed.

Overall Status

Recruiting

Start Date

2019-01-21

Completion Date

2021-01-21

Primary Completion Date

2021-01-21

Study Type

Observational

Primary Outcome

Measure

Time Frame

The identification of vein tissue mechanical distension and stretching properties.

2 years

Enrollment

50

Condition

Eligibility

Study Pop

Study population will consist of individuals under the care of a Vascular Consultant.
Patients will be asked to participate if they are going for a procedure in which there will
be vein tissue waste that would usually be discarded in the operating theatre. The
procedures of interest are Varicose Vein Procedures, Lower Limb Amputation and Lower Limb
Bypass Surgery.

Biospec Retention

Biospec Descr

Patient Data

Sharing Ipd

No

Ipd Description

Vein Tissue will be shared with research collaborators at the Univeristy of Limerick for the purpose of mechanical characterisation.
Patient data will not leave the site of origin. No patient identifiable data will be shared. Vein tissue sample will be labelled with a study number and dated. No patient identifiable data will be labelled on the specimen container.

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Case-Control

Time Perspective

Cross-Sectional

Study First Submitted

July 4, 2019

Study First Submitted Qc

July 9, 2019

Study First Posted

July 11, 2019

Last Update Submitted

July 9, 2019

Last Update Submitted Qc

July 9, 2019

Last Update Posted

July 11, 2019

ClinicalTrials.gov processed this data on September 13, 2019

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.

Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.

Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment
in a small group of people (20-80) for the first time to evaluate its
safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to
a larger group of people (100-300) to see if it is effective and to
further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to
large groups of people (1,000-3,000) to confirm its effectiveness,
monitor side effects, compare it to commonly used treatments, and
collect information that will allow the drug or treatment to be used
safely.